Point of Care (“POC”) and home testing for various blood analytes and other detectable metrics in bodily fluids is desirable for patient and doctor. One such analyte is A1C, a type of glycated hemoglobin. High levels of blood glucose cause over-glycation of proteins, including hemoglobin, throughout the body. Glycation of hemoglobin can occur at the amino termini of the alpha and beta chains, as well as other sites with free amino groups. Hemoglobin A undergoes a slow glycation with glucose that is dependent on the time-average concentration of glucose over the 120-day life span of red blood cells. The most prevalent and well-characterized species of glycated hemoglobin A is A1C, making up approximately 3% to 6% of the total hemoglobin in healthy individuals. The correlation of A1C and blood glucose levels make it a useful method of monitoring long-term blood glucose levels in people with diabetes. The mean (average) blood glucose level (MBG) is a function of the A1C levels and, therefore, is derivable.
Polymer Technology Systems, Inc. (PTS), manufactures the A1CNow®, a Point-of-Care device for measuring HbA1C. This test is an immunochemistry (antigen-antibody)-based system which performs well unless the patient has hemoglobin variances HbS and HbC which create false high results as much as 30%. It would be desirable to provide an assay that is not affected by these hemoglobin variances.